NCT01280994

Brief Summary

The purpose of this study is to develop and evaluate the usefulness of MRI using 129Xe gas for regional assessment of pulmonary function. Specifically, three forms of 129Xe MRI contrast will be the investigators focus - 1) imaging of the 129Xe ventilation distribution, 2) imaging the alveolar microstructure via the 129Xe apparent diffusion coefficient (ADC), and 3) imaging 129Xe that dissolves in the pulmonary blood and tissues upon inhalation. Such imaging of 129Xe gas transfer is expected to be uniquely sensitive to pathologies affecting gas exchange (fibrosis, emphysema, pulmonary hypertension) and provide new insights regarding the normal resting heterogeneity of pulmonary gas exchange.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
445

participants targeted

Target at P75+ for phase_2

Timeline
55mo left

Started Jan 2011

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress77%
Jan 2011Dec 2030

Study Start

First participant enrolled

January 1, 2011

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

January 9, 2011

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 21, 2011

Completed
19.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2030

Last Updated

January 16, 2026

Status Verified

January 1, 2026

Enrollment Period

19.9 years

First QC Date

January 9, 2011

Last Update Submit

January 14, 2026

Conditions

Interstitial Lung Disease

Keywords

Lung DiseasePulmonary DiseaseDiagnostic ImagingMRI

Outcome Measures

Primary Outcomes (1)

  • Number of Participants with Adverse Events as a Measure of Safety and Tolerability

    The purpose of this trial is to examine the ability of HP 129Xe imaging to characterize the lung in healthy and diseased states. The safety endpoint for each subject is to record any adverse events as a measure of safety and tolerability. The technical endpoint for each subject is the acquisition of technically adequate HP 129Xe MR images.

    Day 2

Interventions

Hyperpolarized 129Xenon GasDRUG

Hyperpolarized 129Xenon Gas will be administered in multiple doses in volumes that are tailored to the subject's total lung capacity (TLC) followed by a breath hold of up to 15 seconds. Subsequent 129Xe doses will only be administered once the subject is ready to proceed.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subject has no diagnosed pulmonary conditions
  • Subject has not smoked in the previous 5 years.
  • Smoking history, if any, is less than or equal to 5 pack-years.
  • Subject has a diagnosis of pulmonary dysfunction made by a physician
  • No acute worsening of pulmonary function in the past 30 days

You may not qualify if:

  • Subject is less than 18 years old
  • MRI is contraindicated based on responses to MRI screening questionaire
  • Subject is pregnant or lactating
  • Respiratory illness of a bacterial or viral etiology within 30 days of MRI
  • Subject has received an investigational medicinal product (not including 129Xe) within 30 days of MRI
  • Subject has any form of known cardiac arrhythmia
  • Subject does not fit into 129Xe vest coil used for MRI
  • Subject cannot hold his/her breath for 15 seconds
  • Subject deemed unlikely to be able to comply with instructions during imaging

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

RECRUITING

Related Publications (13)

  • Cleveland ZI, Cofer GP, Metz G, Beaver D, Nouls J, Kaushik SS, Kraft M, Wolber J, Kelly KT, McAdams HP, Driehuys B. Hyperpolarized Xe MR imaging of alveolar gas uptake in humans. PLoS One. 2010 Aug 16;5(8):e12192. doi: 10.1371/journal.pone.0012192.

    PMID: 20808950BACKGROUND

  • Virgincar RS, Cleveland ZI, Kaushik SS, Freeman MS, Nouls J, Cofer GP, Martinez-Jimenez S, He M, Kraft M, Wolber J, McAdams HP, Driehuys B. Quantitative analysis of hyperpolarized 129Xe ventilation imaging in healthy volunteers and subjects with chronic obstructive pulmonary disease. NMR Biomed. 2013 Apr;26(4):424-35. doi: 10.1002/nbm.2880. Epub 2012 Oct 13.

    PMID: 23065808BACKGROUND

  • Kaushik SS, Cleveland ZI, Cofer GP, Metz G, Beaver D, Nouls J, Kraft M, Auffermann W, Wolber J, McAdams HP, Driehuys B. Diffusion-weighted hyperpolarized 129Xe MRI in healthy volunteers and subjects with chronic obstructive pulmonary disease. Magn Reson Med. 2011 Apr;65(4):1154-65. doi: 10.1002/mrm.22697. Epub 2010 Dec 16.

    PMID: 21413080BACKGROUND

  • Roos JE, McAdams HP, Kaushik SS, Driehuys B. Hyperpolarized Gas MR Imaging: Technique and Applications. Magn Reson Imaging Clin N Am. 2015 May;23(2):217-29. doi: 10.1016/j.mric.2015.01.003.

    PMID: 25952516BACKGROUND

  • Kaushik SS, Freeman MS, Cleveland ZI, Davies J, Stiles J, Virgincar RS, Robertson SH, He M, Kelly KT, Foster WM, McAdams HP, Driehuys B. Probing the regional distribution of pulmonary gas exchange through single-breath gas- and dissolved-phase 129Xe MR imaging. J Appl Physiol (1985). 2013 Sep;115(6):850-60. doi: 10.1152/japplphysiol.00092.2013. Epub 2013 Jul 11.

    PMID: 23845983RESULT

  • He M, Kaushik SS, Robertson SH, Freeman MS, Virgincar RS, McAdams HP, Driehuys B. Extending semiautomatic ventilation defect analysis for hyperpolarized (129)Xe ventilation MRI. Acad Radiol. 2014 Dec;21(12):1530-41. doi: 10.1016/j.acra.2014.07.017. Epub 2014 Sep 26.

    PMID: 25262951RESULT

  • Kaushik SS, Freeman MS, Yoon SW, Liljeroth MG, Stiles JV, Roos JE, Foster W, Rackley CR, McAdams HP, Driehuys B. Measuring diffusion limitation with a perfusion-limited gas--hyperpolarized 129Xe gas-transfer spectroscopy in patients with idiopathic pulmonary fibrosis. J Appl Physiol (1985). 2014 Sep 15;117(6):577-85. doi: 10.1152/japplphysiol.00326.2014. Epub 2014 Jul 18.

    PMID: 25038105RESULT

  • Kaushik SS, Robertson SH, Freeman MS, He M, Kelly KT, Roos JE, Rackley CR, Foster WM, McAdams HP, Driehuys B. Single-breath clinical imaging of hyperpolarized (129)Xe in the airspaces, barrier, and red blood cells using an interleaved 3D radial 1-point Dixon acquisition. Magn Reson Med. 2016 Apr;75(4):1434-43. doi: 10.1002/mrm.25675. Epub 2015 May 18.

    PMID: 25980630RESULT

  • He M, Robertson SH, Kaushik SS, Freeman MS, Virgincar RS, Davies J, Stiles J, Foster WM, McAdams HP, Driehuys B. Dose and pulse sequence considerations for hyperpolarized (129)Xe ventilation MRI. Magn Reson Imaging. 2015 Sep;33(7):877-85. doi: 10.1016/j.mri.2015.04.005. Epub 2015 Apr 30.

    PMID: 25936684RESULT

  • Ebner L, He M, Virgincar RS, Heacock T, Kaushik SS, Freemann MS, McAdams HP, Kraft M, Driehuys B. Hyperpolarized 129Xenon Magnetic Resonance Imaging to Quantify Regional Ventilation Differences in Mild to Moderate Asthma: A Prospective Comparison Between Semiautomated Ventilation Defect Percentage Calculation and Pulmonary Function Tests. Invest Radiol. 2017 Feb;52(2):120-127. doi: 10.1097/RLI.0000000000000322.

    PMID: 27662575RESULT

  • He M, Driehuys B, Que LG, Huang YT. Using Hyperpolarized 129Xe MRI to Quantify the Pulmonary Ventilation Distribution. Acad Radiol. 2016 Dec;23(12):1521-1531. doi: 10.1016/j.acra.2016.07.014. Epub 2016 Sep 9.

    PMID: 27617823RESULT

  • Dahhan T, Kaushik SS, He M, Mammarappallil JG, Tapson VF, McAdams HP, Sporn TA, Driehuys B, Rajagopal S. Abnormalities in hyperpolarized (129)Xe magnetic resonance imaging and spectroscopy in two patients with pulmonary vascular disease. Pulm Circ. 2016 Mar;6(1):126-31. doi: 10.1086/685110.

    PMID: 27162620RESULT

  • Robertson SH, Virgincar RS, Bier EA, He M, Schrank GM, Smigla RM, Rackley C, McAdams HP, Driehuys B. Uncovering a third dissolved-phase 129 Xe resonance in the human lung: Quantifying spectroscopic features in healthy subjects and patients with idiopathic pulmonary fibrosis. Magn Reson Med. 2017 Oct;78(4):1306-1315. doi: 10.1002/mrm.26533. Epub 2016 Nov 8.

    PMID: 28940334RESULT

MeSH Terms

Conditions

Lung Diseases, InterstitialLung Diseases

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases

Study Officials

  • Joseph Mammarappallil, M.D.

    Duke University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jennifer Korzekwinski

CONTACT

919-681-7362jennifer.korzekwinski@duke.edu

Cody Blanton

CONTACT

919-668-7575cody.blanton@duke.edu

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

January 9, 2011

First Posted

January 21, 2011

Study Start

January 1, 2011

Primary Completion (Estimated)

December 1, 2030

Study Completion (Estimated)

December 1, 2030

Last Updated

January 16, 2026

Record last verified: 2026-01

Locations

US(1)